Tiotropium / Respimat One Year Study in COPD.

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00387088
First received: October 11, 2006
Last updated: May 7, 2014
Last verified: September 2013
  Purpose

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Device: Respimat
Drug: Tiotropium
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).

  • Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.


Secondary Outcome Measures:
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

  • Number of COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

  • Number of COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

  • Number of Patients With at Least One COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

  • Time to First Hospitalisation for COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation

  • Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

  • Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

  • Number of Patients With at Least One Hospitalisation for a COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ] [ Designated as safety issue: No ]
    Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  • Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  • Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 [ Time Frame: Baseline and Day 169 ] [ Designated as safety issue: No ]
    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  • Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 [ Time Frame: Baseline and Day 337 ] [ Designated as safety issue: No ]
    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  • Marked Changes From Baseline in Vital Signs at End of Treatment [ Time Frame: Baseline and end of treatment ] [ Designated as safety issue: No ]

    Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.

    SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.

    DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.

    PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.


  • Clinically Relevant Findings in Physical Examination and ECG [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
    Clinically relevant findings in Physical Examination and ECG at end of treatment


Enrollment: 3991
Study Start Date: September 2006
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tiotropium
Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Drug: Tiotropium
Placebo
Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
Device: Respimat

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female
  2. At least 40 years old
  3. Smoker or ex-smoker
  4. Smoking history > 10 pack-years
  5. Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria:

  1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
  2. History of asthma or allergic conditions.
  3. Malignancy requiring treatment within past 5 years
  4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
  5. Known active tuberculosis
  6. Known hypersensitivity to anticholinergic drugs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387088

  Show 334 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00387088     History of Changes
Other Study ID Numbers: 205.372, 2006-001009-27
Study First Received: October 11, 2006
Results First Received: November 13, 2009
Last Updated: May 7, 2014
Health Authority: Australia: Responsilble Ethics Committee
Brazil: Ministry of Health
Canada: Health Canada - Therapeutic Products Directorate
China: Food and Drug Administration
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: AFSSAPS
Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte
Great Britain: MHRA
Greece: National Organization for Medicines (EOF) National Ethics Committee
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Ministry of Health and Family Welfare
Ireland: Irish Medicines Board
Italy: Comitato Etico dell'Azienda Osp. Universitaria Pisana - PISA
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority,Ministry of Health
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: Medicines Control Council
Spain: Ministry of Health
Sweden: The National Board of Health and Welfare
Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern
Taiwan: Department of Health, Executive Yuan, Taiwan
Turkey: Ministry of Health Central Ethics Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014